The FDA Modernization Act of 2021: Facilitating Innovative Medical Research through Policy
An Alternatives to Animal Testing, Experimentation and Dissection Article from All-Creatures.org

FROM Center for Contemporary Sciences
July 2021

A key step to accelerate medical innovation is to expand the use of more human-relevant testing methodologies such as cell-based assays, organ chip technologies, and sophisticated computer modeling.

The FDA Modernization Act of 2021: Facilitating Innovative Medical Research through Policy
The discovery of breakthrough therapies has drastically slowed down over the past few decades. A significant contributor is the bottleneck of ineffective animal models and testing. Ninety to 95% of drugs and vaccines found safe in animal tests fail during human clinical trials.

The cost for developing a single new drug may be from $1 - $6 billion (costs that are passed on to the consumer in the form of high drug costs) and takes an average of 10 to 15 years from lab to market.

However, a key step to accelerate medical innovation is to expand the use of more human-relevant testing methodologies such as cell-based assays, organ chip technologies, and sophisticated computer modeling. These human biology-based test methods can be applied to better predict how humans will respond to drugs in clinical trials.

Even though the science of toxicity and drug development testing has been transformed significantly in recent years, in the absence of regulatory acceptance of non animal, science-based test methods, practical change has occurred at a glacial pace.

CCS is pleased to share that over the past few months, it has been a major partner in support of an exciting new policy initiative that will open the doors for more innovation in drug development and reduce the use of animal testing. Earlier this year, representatives Vern Buchanan, R-Fla, and Elaine Luria, D-Virg., have introduced the FDA Modernization Act of 2021 (H.R.2565) to the House of Representatives. This legislation will amend the Federal Food Drug and Cosmetics Act (FFDCA) of 1938 to expand the type of nonclinical test methods for new drugs to include human biology-based, non animal test methods.

The FDA Modernization Act of 2021 would:

• Amend the current FFDCA to authorize the use of the best nonclinical test methods to determine the safety and efficacy of a new drug, whether animal or non animal.
• Broaden options for drug sponsors to use test methods most likely to predict how a drug will react in humans, including state of the art nonclinical models based on human biology.
• Encourage innovation and use of 21st Century science to improve success in clinical trials, bring more treatments to patients sooner, and at less cost.

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